Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis

• Conditions: Left Atrial Appendage Aneurysm; Mitral Stenosis
• Interventions: Other: WARFARIN

• Registration Number: NCT05186649
• Lead Sponsor: University of Karachi

Brief Summary

Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent.

Detailed Description

Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent. Demographic profile of the patients will be recorded like gender and age. And baseline TEE will be interpreted and parameters such as mean MVO (cm2), mean MPG (mmHg), and mean LA size (AP diameter, cm) will be recorded. LAA morphologies will be classified as per the operational definition. All the patients will be put on oral anticoagulation with Warfarin. The international normalized ratio (INR) will be maintained between 2.5 and 3.5. Patients will be prescribed with warfarin initial with 5 mg of daily dosage. Weekly INR monitoring will be performed via weekly calls to each and every patients and their INR level will be obtained. Warfarin daily dosage will be adjusted after every month based on target INR range. Repeat TEE will be performed after three (3) months in all the patients. And presence and absence of clot in different types of LAA will be recorded.

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-01
• Study First Submitted: 2021-12-25
• Study First Submitted QC: 2021-12-25
• Last Update Submitted: 2021-12-25
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Age between 18 to 65 years.
• Both male and female.
• Patients with server mitral stenosis.
• Patients with LAA clot on TEE.
• Patients prescribed with anticoagulation (warfarin therapy).

Exclusion Criteria

• Patients with severe MR
• Patients with severe AS
• Patients with NYHA class IV
• Patients whose valve morphology precluded PTMC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group	WARFARIN	Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent.

Primary Outcome Measures

Name	Time	Method
frequency of left atrial appendage	6 Month	To determine frequency of left atrial appendage (LAA) clot resolution after three months of anticoagulation in patients with severe mitral stenosis.

Secondary Outcome Measures

Name	Time	Method
anatomies of LAA	6 Month	To assess the rate of response in different anatomies of LAA so that non-responders can be refer for surgery on the very first TEE examination.

Trial Locations

Locations (1)

Karachi Institute of Heart Disease; 🇵🇰 Karachi, Sindh, Pakistan